PrimusGFS General Regulations

1 11/01/2015 PrimusGFS General Regulations AZ-N001 Page 1 of 23 PrimusGFS General Regulations Version 11/01/2015 PrimusGFS General Regulations AZ-N001 Page 2 of 23 CONTENTS 1. Introduction 2. Standard Scope 3. Legislation 4. Guidance for the Management of Certification Bodies 5. Audit Duration and Frequency 6. Food Certification Categories 7. Auditor Requirements Qualification/Education Experience Formal Auditor Training Auditor Assessment Technical Supervisor Auditing Scope Continued training Attributes and Competencies 8. Conflicts of Interest 9. Certification Process Application Audit execution 10.

2 Evaluation Conformance by individual questions Scoring system Score calculation per module Automatic failure Special Circumstances Surveillance Audits 11. Requirements for Audit Reports 12. Non conformances and Corrective Actions 13. Certification Decision Evaluation of scores Issuing certification Complaints and Appeals 14. Sanctions 15. Distribution of Audit Reports 16. Extension of Scope of Certification 17. Use of logo and registered Trademark ANNEX 1 - Glossary ANNEX 2 - Flow chart for the Certification Bodies Approval Process v1 ANNEX 3 - Applicability chart 11/01/2015 PrimusGFS General Regulations AZ-N001 Page 3 of 23 1.

3 Introduction a. PrimusGFS is a private scheme that establishes voluntary requirements for the certification of Agricultural sector products (including horticultural, grains, and pulses) at a world-wide level. b. These General Regulations explain the PrimusGFS Certification System and the process to obtain this certification. It also intends to establish communication mechanisms, duties and obligations of the Scheme Owner and of Certification Bodies and applicants who would like to gain certification of their products. 2. Standard Scope a. The scope of PrimusGFS is focused on the Food Safety of those Agricultural sector products (including horticultural, grains, and pulses) designated for human consumption.

4 With that intention, PrimusGFS establishes a series of requirements for managing the production, handling, processing and storing operations, which should be considered for consumers safety. b. The main objective is to accomplish third party verification by the Certification Bodies, for the relevant food safety topics associated with each of their different production stages. Additionally, it establishes a minimum acceptable condition for the performance of the applicants. For this, the Standard has defined three fundamental areas that a company in the Agricultural sector must consider in the production and/or manufacturing their products: i.

5 Food Safety Management System (FSMS) ii. Good Agricultural and/or Manufacturing Practices (GAP and/or GMP) iii. Hazard Analysis Critical Control Points (HACCP) System c. An explanation of the requirements for each of these areas is provided in the current normative documents of the PrimusGFS Scheme: i. PrimusGFS - General Regulations ii. PrimusGFS - Standard iii. PrimusGFS - Checklist iv. PrimusGFS - Questions and Expectations d. PrimusGFS may issue additional normative documents from time to time. e. The normative documents will be reviewed internally every year and if needed, changes will be made. Reissuing of the normative documents will take place every four years or more frequently if needed in response to factors such as significant food safety issues, new regulatory requirements, etc.

6 F. The review of the scheme will be carried out taking into consideration the feedback from all the users, and the changes will be sent for consultation with stakeholders. g. English is the original language of the normative documents. Translations will be made to other languages as needed, to also be issued as official normative documents. The English version is the primary reference source. h. The normative documents and their translations can be found in the PrimusGFS website ( ). i. The scheme owner shall carry out regular reviews of the operation of the scheme and take any necessary action to ensure compliance with GFSI requirements; these reviews shall be part of an internal audit program.

7 11/01/2015 PrimusGFS General Regulations AZ-N001 Page 4 of 23 3. Legislation a. Food Safety legislation differs from one country to another. PrimusGFS has been developed to ensure that where laws, specific guidelines for a product and/or good practices recommendations exist, these practices and parameters are used as a reference for applicant s conformance, establishing minimum acceptable criteria for food safety certification. If there are not documented laws or good practices guidelines, certification scheme users should permit certain degree of risk assessment to meet minimum criteria for food safety certification.

8 4. Guidance for the Management of Certification Bodies a. The certification for PrimusGFS can only be performed by approved Certification Bodies (CBs). Certification activities shall be carried out by personnel who have the competence requirements to meet all management, administrative, technical and auditing functions. b. The CB shall have a documented and implemented quality system that shall contain all the necessary requirements for conformance with the scheme and accreditation programs. The information of the quality system required for accreditation shall always be available to the Scheme Owner. c. There shall be a designated member of the CB staff responsible for the quality system s development, implementation and maintenance.

9 This person, the Scheme Manager will be the contact person with the Scheme Owner for the management of the Scheme. The CB shall maintain records regarding the qualifications, training and experience of the Scheme Manager and all staff involved in the certification process. d. The CB must be accredited for the scope of PrimusGFS according to the ISO/IEC Guide 65, ISO/IEC 17021 or ISO/IEC 17065. The Accreditation Body must be affiliated to the International Accreditation Forum (IAF) and signatory to the Multilateral Recognition Arrangement (MLA). See Annex 1 for a flow chart of the CB approval process. e. The list of approved and provisionally approved CBs will be made publicly available by the Scheme Owner, on the website f.

10 Where the CB has a current ISO/IEC Guide 65, ISO/IEC 17021 or ISO/IEC 17065 accreditation and requests the Accreditation Body for a scope modification or extension to include PrimusGFS , the CB must provide written evidence to notify the Scheme Owner of such circumstances. g. CBs shall be accredited within one year from the date of application to the Accreditation Body. If the accreditation is not obtained within this period the Scheme Owner shall review the situation and appropriate actions will be implemented. h. For those CBs that provide non-accredited services, they shall make publicly available the scope of their accreditation, in order to avoid ambiguity with the accredited services offered.